Evaluation of anxiety by eye movement desensitization and reprocessing therapy and cryotherapy in children aged 6-12 years: a randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- assessment of dental anxiety in children
研究概览
简要总结
A total of 150 children aged 6-12 year old reporting to the department of pediatric and preventive dentistry College of Dental Sciences, Amargadh, Bhavnagar, Gujarat to undergo dental treatment procedures which require administration of LA (infiltration) prior to extraction after the diagnosis and treatment plan.Written informed consent will be obtained from the parent.
Group 1(Control group): 50 children will be subjected to Tender Love Care therapy to assess anxiety. Behavior management will be conducted using the Tender Love Care (TLC) approach, during LA administration (infiltration). TLC is associated with provision of care, attention and affection for children
Group 2(Experimental 1): 50 children will be subjected to eye movement distraction therapy to assess anxiety. Children will be asked to breathe deeply followed by recalling their bad memory and side to side eye movement and not the neck movement. Children will be instructed how to perform Eye Movement Desensitization and Reprocessing therapy prior to the administration of LA (infiltration).
Group 3(Experimental 2): 50 children will be subjected to cryotherapy to assess pain perception. Cryospray soaked cotton pellet will be kept at the site of injection for 60 seconds followed by LA administration (infiltration).
This study is designed as a single blind (participants), randomized controlled trial with two parallel groups. Sample will be randomly allocated to the study groups by block randomization by pressure sensitive paper envelopfor equal distribution of sample size in study group.
In all the groups 2% of lignocaine with 1:80,000 adrenaline [Lidyan, India] and 30 gauge needle [BD Microlane] will be used.
In all the study groups, anxiety will be assessed subjectively by pulse rate by using pulse oximeter (DR VAKU) and objectively by the Raghavandera, Madhuri, Sujata Pictorial Scale (RMS Pictorial Scale) before and immediately after LA administration
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy children without any systemic disease
- •Children of both sexes
- •Children who require local anaesthesia (infiltration) for dental extractions
- •Children of age 6-12 years with bad memory.
排除标准
- •1.Children with Sinus, fistula or abscess 2.Children whose parents refuse to participate in the study.
- •The children who score more than or equal to 20 in PHQ9 (Patient Health Questionnaire).
结局指标
主要结局
assessment of dental anxiety in children
时间窗: before and after local anaesthesia
次要结局
- To evaluate dental anxiety in children before & after local anaesthesia by RMS Pictorial scale & pulse oximeter in 6 to 12 years children(2 years)
研究者
Dr Chelsi Patel
College of Dental Science and Hospital, Amargadh, Bhavnagar, Gujarat